Baxter Healthcare Corp.
Product Description:5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02
Status:Ongoing
City:Deerfield
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Letter
Distribution Pattern:US, Puerto Rico, and Bermuda
Classification:Class I
Product Quantity:402,284 bags
Reason For Recall:Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Recall Initiation Date:20150324
Report Date:20150715

Dextrose

Dextrose

Dextrose Recall

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Questions & Answers

Side Effects & Adverse Reactions

50% Dextrose Injection is hypertonic and may cause phlebitis and thrombosis at the site of injection.

Significant hyperglycemia and possible hyperosmolar syndrome may result from too rapid administration. The physician should be aware of the symptoms of hyperosmolar syndrome, such as mental confusion and loss of consciousness, especially in patients with chronic uremia and those with known carbohydrate intolerance.

The intravenous administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

For peripheral vein administration:

The solution should be given slowly, preferably through a small bore needle into a large vein, to minimize venous irritation.

For central venous administration:

Concentrated dextrose should be administered via central vein only after suitable dilution.

 

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels.

The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. Slow infusion of hypertonic solutions is essential to insure proper utilization of dextrose and avoid production of hyperglycemia.

 

History

There is currently no drug history available for this drug.

Other Information

50% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection for intravenous injection as a fluid and nutrient replenisher.

Each mL of fluid contains 0.5 g dextrose, hydrous which delivers 3.4 kcal/gram. The solution has an osmolarity of 2.53 mOsmol/mL (calc.), a pH of 3.2 to 6.5 and may contain sodium hydroxide and/or hydrochloric acid for pH adjustment.

The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit.

Dextrose, USP is chemically designated C6H12O6 • H2O (D-glucose monohydrate), a hexose sugar freely soluble in water.

Dextrose, hydrous has the following structural formula:

                                                    MM4

Water for Injection, USP is chemically designated H2O.

The syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.

 

Dextrose Manufacturers


  • Remedyrepack Inc.
    Dextrose (Dextrose Monohydrate) Injection, Solution [Remedyrepack Inc. ]
  • Hospira, Inc.
    Dextrose (Dextrose Monohydrate) Injection, Solution [Hospira, Inc.]
  • Mckesson Packaging Services Business Unit Of Mckesson Corporation
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  • Hospira, Inc.
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  • Physicians Total Care, Inc.
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  • Physicians Total Care, Inc.
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  • Agrilabs
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  • Agripharm
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  • Mwi (Vetone)
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  • General Injectables & Vaccines, Inc
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  • General Injectables & Vaccines, Inc
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  • General Injectables & Vaccines, Inc.
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  • Cantrell Drug Company
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  • B. Braun Medical Inc.
    Dextrose Injection, Solution [B. Braun Medical Inc.]
  • Cardinal Health
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  • Baxter Healthcare Corporation
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  • Hospira, Inc.
    Dextrose (Dextrose Monohydrate) Injection, Solution [Hospira, Inc.]
  • Hospira, Inc.
    Dextrose (Dextrose Monohydrate) Injection, Solution, Concentrate [Hospira, Inc.]
  • Hospira, Inc.
    Dextrose (Dextrose Monohydrate) Injection, Solution [Hospira, Inc.]
  • B. Braun Medical Inc.
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  • Cardinal Health
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  • Hospira, Inc.
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  • Hospira, Inc.
    Dextrose (Dextrose Monohydrate) Injection, Solution [Hospira, Inc.]
  • Durvet
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  • Cardinal Health
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  • Durvet
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  • Vettek
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  • Baxter Healthcare Corporation
    Dextrose (Dextrose Monohydrate) Injection, Solution [Baxter Healthcare Corporation]
  • Baxter Healthcare Corporation
    Dextrose (Dextrose Monohydrate) Injection, Solution [Baxter Healthcare Corporation]
  • Baxter Healthcare Corporation
    Dextrose (Dextrose Monohydrate) Injection, Solution [Baxter Healthcare Corporation]
  • Animart
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  • B. Braun Medical Inc.
    Dextrose Injection, Solution [B. Braun Medical Inc.]
  • Baxter Healthcare Corporation
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  • Hospira, Inc.
    Dextrose (Dextrose Monohydrate) Injection, Solution [Hospira, Inc.]
  • Cardinal Health
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  • Cardinal Health
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